FDA.reportPublic FDA data

Eurotrol

Primary DI
08718734960881
Brand
Eurotrol
Company
Eurotrol B.V.
Model
179.002.010
Published
2017-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121468000EUROTROL GAS-ISE METABOLITESEurotrol B.V.2012-06-22JJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718734960881PackageGS110Not in Commercial Distribution
08718734960898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718734960881087187349608818718734960881
08718734960898087187349608988718734960898

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
412925992
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08718734962724CueSee® Coag1340.001.0052025-04-08
08718734962731CueSee® Coag2340.002.0052025-04-08
08718734962748CueSee® Coag3340.003.0052025-04-08
08718734962755CueSee® Coag4340.004.0052025-04-08
08718734962762CueSee® Coag5340.005.0052025-04-08
08718734963035CueSee® Hyperbaric1350.001.0052026-01-07
08718734963042CueSee® Hyperbaric1350.001.0052026-01-07
08718734960621Eurotrol AlbuTrolAlbuTrol Level 1189.001.0022020-10-08
08718734960645Eurotrol AlbuTrolAlbuTrol Level 2189.002.0022020-10-08
08718734962946CueSee® BGEM1344.001.0052025-07-25
08718734962953CueSee® BGEM2344.002.0052025-07-25
08718734962960CueSee® BGEM3344.003.0052025-07-25
08718734962991CueSee® BGEM1344.001.0052025-07-25
08718734963004CueSee® BGEM2344.002.0052025-07-25
08718734963011CueSee® BGEM3344.003.0052025-07-25
08718734963028CueSee® BGEM1 2 3 4 5345.000.0052025-07-25
08718734962779CueSee® Coag1340.001.0052025-04-08
08718734962786CueSee® Coag2340.002.0052025-04-08
08718734962793CueSee® Coag3340.003.0052025-04-08
08718734962809CueSee® Coag4340.004.0052025-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850010224459CareSuperb COVID-19/Flu A&B Antigen Combo External ControlAccess Bio Inc.JJY2026-06-08
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08